Notified BodiesA notified body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of…Unique Device Identifier - UDIThe unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous…ReprocessingHealth institutions reprocessing single-use devicesNational rules on reprocessing of single-use devicesHarmonised standardsHarmonised European standards under the medical devices Regulations are developed by CEN and Cenelec as European standardisation organisations, Combined studies Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnosticsCounterfeiting Counterfeiting of health products is a serious and growing concern, since this practice endangers patients’ safety and health.Custom-made devicesA 'custom-made device’ is made according to a written instruction by any person authorised by national law through their professional qualifications.European Medical Devices Nomenclature (EMDN)The European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database.In-house medical devicesHealth institutions have the possibility to manufacture, modify and use devices in-house. Latest updatesNews announcement16 December 2024COMBINE programme for clinical trials and medical devices endorsed by Member States1 min readNews announcement29 November 2024Dashboard update - Study supporting the monitoring of availability of medical devices on the EU market (29 November 2024)1 min readNews announcement5 November 2024Update - Notified bodies survey on certifications and applications 1 min readNews announcement15 October 2024Update - Notified bodies overview (15 October 2024)1 min readSee all MD Topics of Interest - HighlightsNews announcement10 April 2024A Study and dashboard on reprocessing and reuse of single-use-devices in the EU1 min readStudy supporting the monitoring of availability of medical devices on the EU marketThe UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system.Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activitiesCommission Notice on notified bodies’ audits performed during Covid-19 exceptional circumstancesGeneral publications12 July 2020Commission guidelines on Union-wide derogations for medical devices1 min readGeneral publications26 June 2020List of COVID-19 essential Medical Devices (MDs and IVDs)1 min read DocumentsPublications
Notified BodiesA notified body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of…
Unique Device Identifier - UDIThe unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous…
ReprocessingHealth institutions reprocessing single-use devicesNational rules on reprocessing of single-use devices
Harmonised standardsHarmonised European standards under the medical devices Regulations are developed by CEN and Cenelec as European standardisation organisations,
Combined studies Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics
Counterfeiting Counterfeiting of health products is a serious and growing concern, since this practice endangers patients’ safety and health.
Custom-made devicesA 'custom-made device’ is made according to a written instruction by any person authorised by national law through their professional qualifications.
European Medical Devices Nomenclature (EMDN)The European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database.
In-house medical devicesHealth institutions have the possibility to manufacture, modify and use devices in-house.
News announcement16 December 2024COMBINE programme for clinical trials and medical devices endorsed by Member States1 min read
News announcement29 November 2024Dashboard update - Study supporting the monitoring of availability of medical devices on the EU market (29 November 2024)1 min read
News announcement5 November 2024Update - Notified bodies survey on certifications and applications 1 min read
News announcement10 April 2024A Study and dashboard on reprocessing and reuse of single-use-devices in the EU1 min read
The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system.
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
General publications12 July 2020Commission guidelines on Union-wide derogations for medical devices1 min read
